NCT02719522

Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy

Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 205 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.

Detailed description

Eligible subjects will be treated with the Pipeline™ Flex Embolization Device with Shield Technology™. Subjects will undergo standard of care follow-up visits. Data generated per standard of care will be collected for 1 year beyond the index procedure. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Pipeline™ Flex Embolization Device with Shield Technology™	Pipeline™ Flex Embolization Device with Shield Technology™ utilizes a phosphorylcholine (PC) surface treatment to the implant combined with the PFED delivery system. The Shield Technology™ surface treatment applied to the implant is an inert polymer material created to mimic the outer membrane of a human red blood cell. The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms and is designed to be placed across the opening (or 'neck') of a brain aneurysm and redirect blood flow away from the aneurysm, causing the blood within the aneurysm to clot.

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-08-22
• Completion: 2019-08-22
• First posted: 2016-03-25
• Last updated: 2022-01-11
• Results posted: 2020-07-08

Locations

21 sites across 11 countries: Australia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Spain, United Kingdom